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Money and Medical Devices – Not Even a Whistleblower Can Stand in the Way

Dr. Rajamannan, Northwestern University

OCTOBER 12, 2011 – MassDevice (here) reports on the firing of Dr. Nalini Rajamannan, an associate professor of medicine at Northwestern University, who blew the whistle on a fellow physician for failing to obtain consent from patients before implanting an experimental medical device he invented. Northwestern denies that’s why she was fired September 30, but says she was let go because she was denied tenure following peer reviews.

Dr. Rajamannan believes the real reason is that she challenged a star cardiac surgeon, Dr. Patrick McCarthy, who implanted the Myxo ring, which is experimental, without any informed consent from the patient. The Myxo annuloplasty mitral valve repair ring is made by Edwards Lifesciences Corp. and was invented by Dr. McCarthy.

According to the publication Heartwire, (here) she helped uncover the fact that two patients sued Dr. McCarthy and that one experienced a periprocedural MI during the implantation surgery. One of the lawsuits has reportedly been dropped.

Dr Rajamannan provided information to federal investigators about the oversight. Neither patient reportedly had provided informed consent.

Dr. Rajamannan says her career has taken an “unexpected downward spiral” ever since she brought the issue of the implantation to the attention of hospital officials. She had been warned not to “cross Pat McCarthy” in an attempt to silence her when she first brought her concerns to the chief of cardiology.

 

Dr. Patrick McCarthy, Northwestern University

SUBSTANTIALLY EQUIVALENT AND DIFFERENT?

The Chicago Tribune in a series from May 2011 reports the Myxo and its cousin the IMR ETlogix had been on the market since 2003 with no FDA clearance for safety. As a Class II device, the manufacturer could claim it was substantially equivalent to devices already on the market and gain approval for marketing under the 510(k) approval.

At the same time Edwards Lifesciences sought a patent from the U.S. Patent and Trademark Office for the Myxo claiming there were 40 characteristics that made it distinct from other heart rings on the market. The FDA does not look at patent reviews for medical devices, however after the fact, the FDA’s Dr. Jeffrey Shuren told the newspaper the agency should have required a more thorough premarket approval of the rings because they used different shapes and materials from others on the market.

The company was never fined by the FDA and the Chicago Tribune reports FDA officials said Edwards Livesciences “made an honest attempt” but misinterpreted the law.

 

INFORMED CONSENT, BATTERY AND ASSAULT

Informed consent is an ethical obligation and a legal requirement in all 50 states. According to emedicinehealth (here), informed consent is the process of informing a patient about a procedure, device or drug and giving the patient the time to ask questions and determine whether or not they wish to undergo such a treatment.

The patient has patient autonomy – the right to voluntarily make their own decision about their health and treatment. In legal terms, when a medical professional fails to obtain informed consent before a procedure or test, it is called battery, which is a form of assault.

However if the patient is examined in the routine course of an office visit, implied consent is assumed. In the case of an emergency, or if the person is incompetent to give their agreement, informed consent may be waived.

When there are significant risks involved, the benefits versus risks, alternative treatments, and likelihood the risk could occur should all be disclosed. This is put in writing and the patient will be asked to sign off given written consent that he or she understands, given without coercion or duress.

The American Medical Association tells doctors (here) how to provide informed consent and how to protect themselves from litigation by documenting the informed consent conversation and carrying adequate liability insurance.

“Good documentation can serve as evidence in a court of the law that the process indeed took place. A timely and thorough documentation in the patient’s chart by the physician providing the treatment and/or performing the procedure can be a strong piece of evidence that the physician engaged the patient in an appropriate discussion. A well-designed, signed informed consent form may also be useful, but an overly broad or highly detailed form actually can work against you. Forms that serve mainly to satisfy all legal requirements (stating for example that “all material risks have been explained to me”) may not preclude a patient from asserting that the actual disclosure did not include risks that the patient unfortunately discovered after treatment. At the other extreme, listing all of the risks may not be wise either. A comprehensive listing will be difficult for the patient to understand and any omission from the list will likely be presumed undisclosed.”

Physicians are encouraged to discuss the language with their attorney.  #

 

3 Comments

  1. Denise Jacobs says:

    Implanting an experimental device without informed consent is morally and ethically WRONG, WRONG, WRONG. Thank you for speaking out, Dr. Rajamannan. I’m sorry that it sounds like you lost your job over it.

    A quote by William Falkner…. “Never be afraid to raise your voice for honesty and truth and compassion against injustice and lying and greed. If people all over the world would do this…., it would change the earth.”

    • Jane Akre says:

      Denise-

      In the case of informed consent and surgical mesh – how can a doctor give a patient enough information to form the basis of informed consent? There are no follow up studies, no data available on the real numbers of adverse reactions. Last I heard Johnson & Johnson was still saying 1%, even the FDA doesn’t agree with that. Really- don’t you have to do clinical studies to provide an accurate picture of the risks v. benefits?

  2. Denise Jacobs says:

    The best way I can answer that is to use the words in a letter published online Sept 2009 by The International Urogynecological Journal in response to ACOG (American Obstetrics and Gynecology) removing the word “experimental” when referring to “trocar-and-mesh operation kits” from its practice bulletin. When discussing informed consent, the letter writer ponders that without “clear data demonstrating the safety and efficacy of these kits, it is unclear how a patient can be counseled adequately about the likely outcomes and the potential catastrophic vaginal injuries that are seen clinically.”

    Transvaginal mesh (TVM) kits remain on the market. TVM surgeons like to say that the problems are from the “old mesh” and that the “newer products are better” but there are many, many women harmed by the “new and improved” products also. SUI mesh as well as POP mesh.

    The FDA did not increased warnings for SUI TVM because the panel “thinks” the complications are “manageable”, yet they do not have many well-constructed studies to back their “opinion” up because premarketing studies and postmarketing followup were never required to be done. “Vaginal mesh erosion” has only been an insurance code for a few years, and apparently became necessary as the complication was being seen more often clinically with the exploding use of “mesh kits”. In my opinion, women have been used as guinea pigs and have not had informed consent.

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